Regulating biosimilars: the three guidelines

The regulation of similar biological medicinal products (‘biosimilars’) is governed by article 10(4) of Directive 2001/83 as amended, supplemented by the annex to the directive. The annex in turn refers to a guideline published by the EMA that governs how biosimilars are to be assessed. There are three guidelines that apply to all biosimilars: an ‘overarching’ guideline that was adopted in September 2005; and two further guidelines that were both adopted by the EMA on 22 February 2006, one relating to non-clinical and clinical issues and one to quality issues. These guidelines are supplemented by a number of product- or class-specific guidelines, also issued by the EMA.

Since 2006, the EMA has gained much experience in biosimilars; it has authorised 14 biosimilars and issued scientific advice relating to many more. In 2011, the EMA therefore started a review of the overarching guideline, the non-clinical and clinical issues and quality issues guidelines so that they could be revised to reflect the way that applications for marketing authorisations for biosimilars are currently being considered. The EMA has now adopted draft versions of the revised guidelines and released them for consultation.

The issues addressed by these guidelines are overlapping but distinct. It is interesting at this stage to consider what the EMA’s thinking is in relation to the big issues that were raised for each of the guidelines…

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